United States Patent 6,977,077: What Does It Actually Claim, and How Broad Is the Scope?
US Drug Patent 6,977,077 covers a method of treating osteoporosis by giving human parathyroid hormone (1-34) at 20 micrograms daily, with a defined background therapy constraint and a defined vitamin D restriction, aimed at reducing fracture risk. The patent is tightly framed around a specific dosing regimen and administration rules that directly narrow infringement scope.
What is the core claim concept and treatment recipe?
Claim 1 is the independent claim and defines the treatment “recipe” along four axes: (i) disease and endpoint, (ii) active ingredient identity, (iii) dose and dosing frequency, and (iv) exclusions about concurrent drugs and vitamin D form.
Independent claim 1 (key elements)
Claim 1 requires all of the following:
-
Purpose / indication
- Treatment of osteoporosis in a human
- For reducing risk of vertebral and non-vertebral bone fracture
-
Active
- Human parathyroid hormone (1-34)
- The claim uses the phrasing “human parathyroid hormone (1–34)” (i.e., hPTH(1-34)).
-
Administration constraint (no antiresorptive co-therapy beyond limited exceptions)
- Administering hPTH(1-34)
- Without concurrent administration of an antiresorptive agent other than vitamin D or calcium
- This means the method does not permit co-treatment with antiresorptives such as bisphosphonates or denosumab, except that vitamin D or calcium are allowed.
-
Dose and regimen
-
Vitamin D limitation
- “Wherein said vitamin D is not a hydroxylated vitamin D or hydroxylated vitamin D metabolite.”
- This excludes use of hydroxylated vitamin D forms/metabolites even if vitamin D (non-hydroxylated) is otherwise permitted.
These elements are not written as optional features. The claim is written as a single method requiring that the patient be treated in the manner described.
Is claim scope wide or narrow? (Infringement math)
The claim is narrow to moderate in practice. It is narrow because:
- It is limited to a single molecule identity and sequence (hPTH(1-34)), not a class of PTH analogs broadly.
- It is limited to a single dose (20 μg/day), not a range.
- It is limited to a specific co-therapy rule: no antiresorptive co-administration other than vitamin D or calcium.
- It adds an additional qualifier: vitamin D must not be hydroxylated vitamin D or hydroxylated vitamin D metabolite.
It is only moderately broad because it covers any human osteoporosis patient meeting the exclusions, and it does not specify route, setting, or specific comparator trial design. But the dose, drug form, and co-therapy restrictions materially constrain infringement.
How do the dependent claims further narrow coverage?
What does claim 2 add?
Claim 2 narrows claim 1 by patient subgroup:
- “The human subject is a man or post-menopausal woman.”
That means non-menopausal women and other osteoporosis populations (e.g., premenopausal, secondary etiologies outside the steroid frame in claim 3) are not covered by claim 2, even if claim 1 would otherwise read on them.
What does claim 3 add?
Claim 3 narrows claim 1 to a specific etiology:
- “Osteoporosis is steroid-induced.”
This narrows to patients whose osteoporosis is attributed to steroid exposure.
What is the effective claim interpretation for key limitations?
1) “Human parathyroid hormone (1–34)”
The claim language requires hPTH(1-34) rather than generic “parathyroid hormone” or longer fragments.
- Practical effect: methods using different parathyroid hormone forms (other fragments, full-length PTH, or analogs) do not automatically fall within the literal text.
2) “Daily dose of 20 μg”
This is a bright-line dosage limitation.
- Practical effect: use of a different daily amount likely falls outside literal claim coverage.
- The claim does not state “about” or “approximately,” so “20 μg” reads as a specific value.
3) “Without concurrent administration of an antiresorptive agent other than vitamin D or calcium”
This limitation is a co-therapy exclusion:
- It bars concurrent administration of any antiresorptive agent (beyond vitamin D and calcium).
- It implies that if an antiresorptive is given concurrently, the method is not met.
4) “Vitamin D is not a hydroxylated vitamin D or hydroxylated vitamin D metabolite”
This is a further refinement of permitted vitamin D background.
- Practical effect: if the allowed vitamin D is limited to non-hydroxylated forms, then vitamin D products that are hydroxylated (or supplied as hydroxylated metabolites) are excluded.
Patent landscape: where this claim sits vs. adjacent osteoporosis and PTH IP
How does this method claim relate to typical osteoporosis IP buckets?
In US osteoporosis portfolios, claims usually fall into these buckets:
- Composition-of-matter for specific drugs (e.g., PTH analog molecules).
- Method-of-use for treating osteoporosis with a specific active ingredient and regimen.
- Method-of-use with combination therapy rules (sequence and co-administration limitations).
- Second-generation analogs that use modified PTH fragments and different dosing paradigms.
US 6,977,077 is firmly in bucket 2 with combination-therapy style constraints (bucket 3) embedded as exclusions.
What does the “no concurrent antiresorptive” rule do to the landscape?
It positions this patent against combination regimens and makes it difficult for a competitor to avoid by using the same molecule but changing background therapy. If a commercial regimen involves concurrent antiresorptives, it helps avoid literal infringement of claim 1.
Conversely, if a competitor targets a regimen that matches:
- hPTH(1-34)
- 20 μg/day
- fracture-risk reduction endpoint framing
- no antiresorptive co-therapy other than non-hydroxylated vitamin D or calcium
then the patent becomes a direct barrier.
What is the “vitamin D not hydroxylated” term doing to design-around?
This limitation gives room for design-around via selection of vitamin D formulation. Many osteoporosis regimens in clinical practice involve active vitamin D analogs or hydroxylated metabolites.
- If a competitor’s background uses hydroxylated vitamin D or hydroxylated metabolites, it is outside the literal scope of claim 1’s vitamin D qualifier.
This is a structural limitation that can carve out infringement even if everything else matches.
Scope map: claim-by-claim coverage grid
| Claim |
Patient population constraint |
Active ingredient requirement |
Dose constraint |
Co-therapy constraint |
Vitamin D restriction |
Endpoint language |
| 1 |
Any human with osteoporosis |
Human PTH (1-34) |
20 μg daily |
No concurrent antiresorptive other than vitamin D or calcium |
Vitamin D is not hydroxylated vitamin D or hydroxylated metabolite |
Reduce risk of vertebral and non-vertebral fractures |
| 2 |
Man or post-menopausal woman |
Same as claim 1 |
Same as claim 1 |
Same as claim 1 |
Same as claim 1 |
Same as claim 1 |
| 3 |
Steroid-induced osteoporosis |
Same as claim 1 |
Same as claim 1 |
Same as claim 1 |
Same as claim 1 |
Same as claim 1 |
How to assess freedom-to-operate risk using the claim elements
A meaningful FTO assessment for method-of-use patents hinges on whether a planned regimen meets all elements of claim 1.
Element checklist for a proposed regimen
To fall within claim 1, a regimen must satisfy every line:
- Disease: osteoporosis in a human
- Active: hPTH(1-34)
- Dose: 20 μg daily
- Co-therapy: no concurrent antiresorptive except vitamin D or calcium
- Vitamin D form: vitamin D must not be hydroxylated vitamin D or hydroxylated metabolite
- Intended purpose: reduce risk of vertebral and non-vertebral fracture
Fast design-around levers implied by the text
Because the claim is built with explicit exclusions, design-around opportunities typically come from shifting one of the constrained axes:
- Avoid concurrent antiresorptive co-administration rule by using an antiresorptive concurrently (if clinically acceptable and if the regimen is not still captured by other claims or doctrine arguments in a full prosecution record).
- Use hydroxylated vitamin D or hydroxylated vitamin D metabolites so that the “not hydroxylated” qualifier is not met.
- Change dose away from 20 μg/day (and ensure the regimen does not still literally hit 20 μg/day).
- Avoid using hPTH(1-34) by switching to a different parathyroid hormone form or analog.
Those levers are direct consequences of the claim’s limiting language.
Key Takeaways
- US 6,977,077 is a method-of-treatment patent centered on hPTH(1-34) at 20 μg daily for osteoporosis with the purpose of reducing vertebral and non-vertebral fractures.
- Claim 1 narrows coverage through two major constraints: (i) no concurrent antiresorptive agent other than vitamin D or calcium, and (ii) vitamin D must not be hydroxylated vitamin D or a hydroxylated vitamin D metabolite.
- Claim 2 further limits coverage to men and post-menopausal women.
- Claim 3 further limits coverage to steroid-induced osteoporosis.
- For landscape and FTO, the most relevant “risk triggers” are the exact dose (20 μg/day), the specific PTH fragment (1-34), and the background therapy profile, especially anti-resorptives and the vitamin D formulation type.
FAQs
1) Does the patent cover all parathyroid hormone therapies for osteoporosis?
No. Claim 1 requires human parathyroid hormone (1-34).
2) What dose does claim 1 require?
A daily dose of 20 μg.
3) Can patients be taking bisphosphonates concurrently under claim 1?
Claim 1 requires no concurrent administration of an antiresorptive agent other than vitamin D or calcium, so concurrent bisphosphonate use is outside claim 1’s literal requirements.
4) Does the patent permit vitamin D supplementation?
Yes, but only vitamin D that is not hydroxylated vitamin D or a hydroxylated vitamin D metabolite.
5) How do claims 2 and 3 change coverage?
They add subgroup limitations: claim 2 covers men or post-menopausal women, and claim 3 covers steroid-induced osteoporosis.
References
- US Patent No. 6,977,077.
